Summary:
Summary Statement of Deficiencies D0000 An announced focused survey for compliance with SARS-CoV-2 test result reporting requirements was conducted virtually for Tidewater Emergency Medical Services on November 30, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey also included interviews and remote record review with the EMS Council Regional Field Coordinator and Team Leads on 11/30/21, and 12/02/21 respectively. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as the following and include: 42 CFR part 493 CLIA Regulation: D1002- 42 CFR. 493.1100 Condition Reporting of SARS-CoV-2 test results. D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on interviews, testing record reviews, and lack of documentation, the facility failed to report seventeen (17) negative and one (1) positive COVID-19 results to the state public health department on four (4) of twenty-five (25) test dates reviewed during the timeframe of April 1, 2021 to November 30, 2021. Findings include: 1. During an interview with the EMS Council Regional Field Coordinator on 11/30/21, at approximately 10:00 AM, the inspector was informed that the agency had utilized Abbott BinaxNOW COVID-19 Ag Cards for rapid SARS-CoV-2 testing from April 2021 and up to the date of the survey. The inspector requested to review the test procedure, policy related to SARS-CoV-2 test reporting, and evidence of reporting results to the state agency. 2. The Regional Field Coordinator stated on 11/30/21 at approximately 11:00: "Our protocol to date has been to report COVID-19 test results Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- to the state or local public health department. I will have to get with my staff team leads to provide the records for review". 3. A review of the available BinaxNOW test logs from 04/01/21 to 11/30/21 revealed fifty-nine (59) COVID-19 test results were reported on 25 testing days. The inspector noted that 1 of the 59 tests was resulted as positive. The inspector requested evidence of the facility reporting the 1 positive and 58 negative results to the state agency. No reporting documentation was available for review for the following 4 days: 08/17/21: 1 negative 08/23/21: 13 negatives, 1 positive 09/20/21: 2 negatives 09/24/21: 1 negative The Regional Field Coordinator stated on 12/02/21 at approximately 3:30 PM: "We do not think reporting was submitted as required for the dates you requested to review. We have had staff changes and cannot locate the former lead's records." 4. An exit interview with the Regional Field Coordinator and team leads on 12/02/21 at approximately 4:00 PM confirmed the above findings. -- 2 of 2 --